Tagged as: Susvimo

Ranibizumab Updates: FDA approval of Roche’s Refillable Ocular Implant and FDA Acceptance of Bioeq’s BQ201 BLA

On October 22, 2021 Roche announced the FDA’s approval of its ranibizumab intravitreal injection, marketed as Susvimo.  Susvimo is a refillable ocular implant—requiring refills every six months—that continuously delivers medicine into the eye for the treatment of neovascular or wet age-related macular degeneration, a condition that can cause rapid and…

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FDA Approvals and Applications Update

On October 22, 2021, the FDA approved Genentech’s SUSVIMO (ranibizumab injection) for wet age-related macular degeneration (AMD) based on positive results from an open-label Phase III study. According to the Genentech press release, SUSVIMO, previously called Port Delivery System with ranibizumab, offers an alternative route of administration for anti-VEGF in…

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